GE Healthcare seeks EU permission to manufacture Optison

GE Healthcare is to seek European regulatory approval to manufacture its Optison 0.19 mg/ml dispersion for injection product at its own facility in Norway.

The company has submitted an application to the European Medicines Agency to amend its marketing authorisation for the imaging agent, allowing it to be supplied via GE Healthcare's manufacturing site in Oslo.

A transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease, Optison is designed to provide opacification of cardiac chambers and enhance left ventricular endocardial border delineation to improve wall motion visualisation.

GE Healthcare is looking to amend its manufacturing arrangements of the product in order to meet market demand more effectively, while ensuring that stock levels are within its control.

Ben Newton, global product leader for ultrasound at GE Healthcare Medical Diagnostics, said: "GE Healthcare is committed to providing safe, reliable, innovative and effective diagnostic products that aid in the detection of cardiovascular diseases, and today's filing is further evidence of our commitment."

Last month, the company unveiled a pair of new magnetic resonance imaging scanners, the Optima MR360 Advance and Brivo MR355 Inspire.